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ClinicalTrials.gov Identifier: NCT00831480

Recruitment Status
:
Terminated
(Difficulty in accrual and by the order of the cancer center.)

The purpose of this multicenter, pilot, open-label, Phase II clinical trial is to discover if Everolimus(RAD001) is safe and effective in people who have advanced kidney cancer (renal cell carcinoma - RCC).

Since 2002, Everolimus has been studied in more than 2500 patients with various types of cancer as a single agent (a drug that is used alone to treat the cancer) or in combination with a number of well known anticancer therapies. Various studies, in animals such as in mice with cancer and in humans with cancer have shown that Everolimus can slow the growth of cancer.

Everolimus will be taken in pill form by mouth daily for 3-5 weeks followed by surgery to remove the effected kidney. After 2-4 weeks following the surgery, Everolimus will be resumed at the same dose.

Condition or disease

Intervention/treatment

Phase

Kidney Cancer

Drug: everolimus

Phase 2

Detailed Description:

Everolimus has significantly improved outcomes following prior therapy. This study is a biomarker driven Phase II trial that will assess the activity of everolimus as first-line therapy for renal cell carcinoma. Following initial kidney tumor biopsy, everolimus is administered for 3-5 weeks before cytoreductive nephrectomy and everolimus is then resumed and continued until tumor progression or intolerable toxicities. Any correlation of tumor tissue biomarker changes from initial biopsy to nephrectomy specimen with long-term progression-free survival will be determined. This trial may enable the identification of factors predictive of significant benefit from everolimus administered as first-line therapy by employing the neoadjuvant therapy paradigm.

Disease Progression Diagnosed by Biopsy [ Time Frame: up to one year ]

Clinical progression validated by biopsy of metastatic site. Progression-free survival (PFS) will be measured from the post-op treatment start date to either the date the patient is first recorded as having disease progression, or the date of death if the patient dies due to any causes before progression. If a patient is lost to follow-up or removed for toxicities, the patient will be censored as of the last date of contact. Patients who start a new treatment before they progress will be censored as of the date of start of the new treatment. If a patient has not progressed or died, PFS is censored at the date of last follow-up. Patients removed from therapy with everolimus due to toxicities will not be included in the PFS estimation.

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Other malignancies within the past 3 years except for localized carcinoma of the cervix, basal or squamous cell carcinomas of the skin, or localized prostate cancer with Gleason Score less than 7 treated with radiation or surgery and no evidence of progression.

Major surgery (defined as requiring general anesthesia) or significant traumatic injury within 4 weeks of start of enrollment

Anticipated major surgery (other than CN) during the course of the study

A known history of HIV seropositivity

Hepatitis C seropositivity

Chronic, systemic treatment with corticosteroids or another immunosuppressive agent. Topical or inhaled corticosteroids are allowed.

Immunization with attenuated live vaccines within one week of study entry or during study period

Known hypersensitivity to RAD001 (everolimus) or other rapamycins or to its excipients

Impairment of gastrointestinal function or gastrointestinal disease

Active, bleeding diathesis

Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods.

History of noncompliance to medical regimens

Unwilling to or unable to comply with the protocol including mandated biopsies